Various types of patient medical data are valuable pieces of information with respect to a variety of medical practices. These medical practices may include treating, diagnosing, monitoring, and performing clinical trials. Clinical trials are often performed to determine the effect a particular drug may have on a particular type of patient or patients in general. During clinical trials, medical data regarding participating patients needs to be submitted over a period of time. For example, medical data may be required to be submitted before receiving a drug, on a periodic basis while taking a drug, and after the patient has stopped taking the drug.
One type of medical data commonly required during a clinical trial is data from an electrocardiogram (ECG or EKG). To obtain an ECG, medical personnel attach up to 12 leads to various areas on a patient's body. The leads are connected to a device that is able to monitor and record, electronically, the electrical signals measured by the leads with respect to time. The device may be able to display the obtained measurements graphically.
All or part of a patient's medical data may be reviewed by individuals obtaining the data, the person or entity supervising the clinical trial, and a data management company. For instance, during clinical trials involving a drug being administered to a patient, generally an ECG is performed on the patient, and data obtained from the ECG is reviewed, to monitor the patient's health and the effect the drug may have on the patient's heart. ECG data is often sent to other locations besides a testing clinic for review. The ECG data, for example, may be sent to a cardiologist for review and generation of a report based on the data. Clinical trial ECG data generally must be handled confidentially and with great care to ensure the integrity of the clinical trial. Furthermore, the review of the data often must occur relatively quickly, such as within 24 hours, in order to adequately and safely monitor the patient's health.
Conventional processes for reviewing ECG data have involved faxing the ECG data to a data management company. The data management company employs trained technicians that review the data and perform measurements on the ECG data graph to determine information such as a QT, PR, ST, and RR interval. The following, in a non-limiting way, discloses examples of values and how they are determined. The QT interval is measured from the beginning of the QRS complex to the end of the T wave. The QT interval is important for diagnosing prolongation or shortening of the QT interval. A long QT interval signifies an abnormally long delay between the electrical excitation (or depolarization) and relaxation (repolarization) of the ventricles of the heart. A short QT interval involves short QT values that do not significantly change with the heart rate. The QRS value corresponds to the current that causes contraction of the left and right ventricles of the heart. The T wave represents the repolarization of the ventricles.
The PR value is determined as the distance between a P wave and R wave. A P wave is the electrical signature of the current that causes atrial contraction. Its relationship to QRS values determines the presence of a heart block. The R wave indicates contraction of the myocardium, or the muscular tissue of the heart, itself. The ST interval is measured from the QRS complex to the T wave. Like the R wave, the S wave indicates contraction of the myocardium, or the muscular tissue of the heart, itself. The RR value is the interval from the onset of one QRS complex to the onset of the next QRS complex.
A cardiologist is employed to review the ECG and the technician's measurements for accuracy and to create a report. The resulting report is faxed back to the clinical testing center for the patient's records. The report is also faxed to the data management company to collect the information for clinical drug trial reporting purposes.
Recently, computerized systems have been implemented to create, modify, maintain, archive, retrieve, and transmit clinical data. Computerized systems assist data management companies in collecting, handling, and securing clinical trial data. Utilizing a computerized system, ECG data may be transmitted electronically to the data management companies' trained technicians. The technicians are then able to measure the ECG on a computer system screen by using cross hairs associated with a mouse cursor to obtain measurements based on a location of the mouse cursor. Additionally, the technician is able to transmit, electronically, the ECG and measurements from the ECG to a cardiologist for review and generation of a report. The computerized systems allow the technician, cardiologist and the storage facility to be in separate places, including on separate continents, and then allows all concerned to benefit from ideal locations of capacity, data storage, medical expertise, and technical and other desired capacity. Finally, computerized systems provide the ability to electronically transmit ECG data and reports to the clinical trial organizers and to the Federal Drug Administration (FDA) in a format acceptable to the FDA.
Conventional computerized data management systems, however, do not provide sufficient data management processes for securely, efficiently, and safely transmitting and analyzing ECG data. For instance, conventional data management techniques do not provide workflow management functions that promote quick and efficient review of ECG data and reporting. Conventional data management techniques do not provide a high level of security and audit trails to safeguard patient confidentiality and the integrity of the clinical trial. In addition, conventional systems do not provide for automatic quality control procedures to ensure consistency and accuracy with respect to the patient's data. Various embodiments of the present invention, therefore, provide a data management process that includes a high level of patient data security, clinical trial integrity, quality control, workflow management, and ECG review and reporting.